Status:
COMPLETED
An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-78 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare reduction in A1C for subjects taking Saxagliptin and Metformin XR vs. uptitrated Metformin XR.
Eligibility Criteria
Inclusion
- Type 2 diabetics taking metformin IR or XR greater than or equal to 850mg and less than or equal to 1500mg only for at least 8 weeks prior to screening
- A1c: 7.5-11% (at screening)
- BMI less than or equal to 45 kg/m2
Exclusion
- Significant cardiovascular history
- Active liver disease, renal impairment
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00960076
Start Date
August 1 2009
End Date
October 1 2010
Last Update
September 27 2011
Active Locations (35)
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1
Research Site
Jonesboro, Arkansas, United States
2
Research Site
Anaheim, California, United States
3
Research Site
Fountain Valley, California, United States
4
Research Site
Los Angeles, California, United States